Pharmacists, manufacturers and wholesalers across Europe must share data on medicines shortages to stop them getting even worse, a review of the supply chain has concluded.

Shortages affected patients "every day, everywhere" and were getting worse in every country in Europe, according to the review by Swiss management consultancy firm Birgli, published this month and seen first by C+D.

Sharing data on shortages could be "the political and commercial equivalent of Pandora's box", the report's authors said, but was the only way to make informed decisions about what action should be taken.

"The issue is not a lack of data, but an unwillingness to share it by each stakeholder – and we do mean each stakeholder," they said.

"The issue is not a lack of data, but an unwillingness to share it by each stakeholder," said the report	More stock shortage news 'Jumping through hoops' to get medicines Pharmacy challenge takes on ‘anti-competitive' drug quotas in court Pharmacists hit back at Howe's call for proof of harm from shortages
	The authors examined how medicines shortages were affecting the UK, France, Greece, Poland and Spain by speaking to stakeholders in each country, including pharmacists, wholesalers, manufacturers, hospitals, legislators and parallel distributors.

They identified several causes of shortages across Europe, including quotas, manufacturing problems, unexpected demand and parallel trading. However, there was no "single primary cause" for the problem, they said.

In the UK, quotas were a "major source of concern" for stakeholders, with disruptions caused by a reduced number of wholesaler deals an important cause, the review found. It highlighted C+D's findings that pharmacists spent an average of 15 hours a month contacting wholesalers and manufacturers about shortages last year. But there was no quantitative data available to determine a breakdown of causes in the UK, it said. Improved communication between European regulators and supply chain stakeholders was "critical" in resolving these shortages, the authors added. Failure to find a solution quickly could result in "legislated solutions" that would not provide the greatest benefit to patients. The European Association of Euro-Pharmaceutical Companies (EAEPC), which represents the licensed parallel distribution industry and commissioned the report, said it was ready to begin "comparing notes" about shortages with other stakeholders.

What the report said about: Quotas Pharmacies in all markets indicate they have exceeded their quotas for some products. What began as a tool to reduce parallel distribution has become a filter and a class of shortages in its own right. Parallel distribution With pharmacies and wholesalers under such heavy pressure to support their bottom lines, it is understandable that some turn to parallel distribution, despite a clear industry position against the business. Manufacturers The review concluded it did not have sufficient information to determine the real impact of manufacturing factors on shortages. Wholesalers Wholesalers have also been affected by price and margin reductions over the past few years. In response, they have made their supply chains even more effective and streamlined than before. Source: An evaluation of medicine shortages in Europe, Birgli, published October 2013

The EAEPC blamed shortages on quota systems, which it said had "spread like wildfire" across the pharmaceutical wholesaler market in Europe and were often unable to respond quickly enough to fluctuations in medicine demand. The effect of the export of medicines had been "blown out of proportion", it said, as the overall level of parallel trade within Europe had remained "relatively flat" for the past five years.

Parallel trade was bound to occur and had actually helped struggling pharmacies and wholesalers in many countries by providing extra revenue, it said. However, there were "significant fluctuations" in the level of export between countries, it added, with changing currency values encouraging individuals to export medicines from the UK.

Richard Freudenberg, the EAEPC's chief executive, told C+D he would be sharing the report with all the organisation's members and discussing the findings with the heads of medicines agencies across Europe.

C+D is now collating evidence of medicines shortages to present to pharmacy minister Earl Howe, in response to his call in August for pharmacists to prove that stock shortages were harming patients.

How Europe is battling with shortages

United Kingdom

In the UK, manufacturers blamed shortages on parallel trading, which caused them to put quota systems in place. Pharmacies, hospitals, wholesalers and prescribers pointed to these quotas as the main reason for shortages. They also blamed disruptions in the supply chain caused by the implementation of restricted wholesaler deals. In the case of generics, manufacturing issues was the biggest concern.

As well as shortages in primary care, there is a growing concern about medicines not being delivered in time in secondary care. Hospitals have up to 400 medicines exceeding their expected delivery times, although only a few of these are causing critical shortages.

France

Shortages are caused by manufacturing issues, quotas, parallel trading and increases in demand. Wholesalers, distributors and pharmacists have all contested the quota systems put in place by manufacturers.

Wholesalers claimed that parallel trade was not a major cause of shortages, and blamed market withdrawals, ingredient shortages and low stock levels in pharmacies. Pharmacies in France are well informed about shortages. However they face similar shortage-related problems as their equivalents in other countries and shortages can affect up to 15 per cent of orders that pharmacies place.

The French medicines watchdog is currently conducting a review of shortages, to be published in October 2014. The government is expected to put in place new legislation to reduce shortages after that date.  

Greece

The financial crisis has resulted in shortages of hundreds of drugs, and pharmaceutical sales have fallen by 29 per cent since it began. Parallel trade is seen as the biggest cause of shortages, with price cuts making Greece a prime location for wholesalers to export cheap products.

Price cuts and austerity measures have also caused hospitals and pharmacies liquidity issues, which have made it harder for them to stock products. These combined factors have created a "perfect storm" of shortages. Many patients are often unable to get their medicines from the health service and instead have to buy them in other countries. Despite "heart-breaking" cases of patients unable to get medicines, there are no "ready and quick solutions" to shortages.

Poland

Poland is a low-priced market, with generics costing about 43 per cent less than in the rest of Europe. As a result, pharmacists and wholesalers are often involved in exporting medicines. Manufacturers had put quotas in place, and there was evidence low prices had caused them to remove products from the market.

Pharmacies can order directly from a number of manufacturers, but they are often faced with expensive minimum purchase requirements that also result in shortages.

A Reimbursement Act reduced pharmacy margins and prevented many businesses from remaining profitable. This means that up to 70 per cent of patients now have to return to the pharmacy 24 hours after bringing their prescription, due to limited stock availability.  

Spain

The financial crisis has caused delays in reimbursement payments to pharmacies. There is also a concern that the national health service is no longer sustainable and there are cases of irregular medicines supplies in certain regions because of financing problems.

The general view is that medicines export has decreased in recent years, due to pricing changes. Spain has introduced regulations that have affected shortages, including bringing down medicines prices and introducing a system of medicines co-payments for patients.

Source: An evaluation of medicine shortages in Europe, Birgli, published October 2013

Do you have evidence of stock shortages causing patient harm that we can show Earl Howe? Comment below or email us at [email protected] You can also find C+D on Twitter, LinkedIn and Facebook